Smart packaging for improved medication regimen compliance

ABSTRACT

The present disclosure enables apparatus and methods for tracking medications and/or product units via smart-packaging concepts. Embodiments include sensors that monitor the state of a blister-card package having an unpatterned lidding film by measuring the impedance of each dispensing region of the lidding film that defines a portion of a blister. In some embodiments, the impedance is measured via a plurality of contact points arranged on opposite sides of each dispensing region, where the contact points are resistively or capacitively coupled with the lidding film. In some embodiments, the impedance map of a measurement region on the blister card is derived via electrical impedance tomography or electrical resistance tomography, where the measurement region includes a plurality of dispensing regions.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation of co-pending U.S. patent applicationSer. No. 16/825,981, filed Mar. 20, 2020, entitled “Smart Packaging forImproved Medication Regimen Compliance,” (Attorney Docket: 3005-008US2),which is a continuation of U.S. patent application Ser. No. 16/156,603,filed Oct. 10, 2018, entitled “Smart Packaging for Improved MedicationRegimen Compliance,” (Attorney Docket: 3005-008US1), which claims thebenefit of U.S. Provisional Patent Application Ser. No. 62/570,328,filed Oct. 10, 2017, entitled “Smart Packaging for Improved MedicationRegimen Compliance,” (Attorney Docket: 3005-008PR1), each of which isincorporated herein by reference.

If there are any contradictions or inconsistencies in language betweenthis application and the case that has been incorporated by referencethat might affect the interpretation of the claims in this case, theclaims in this case should be interpreted to be consistent with thelanguage in this case.

TECHNICAL FIELD

The present disclosure relates to packaging in general, and, moreparticularly, to smart packaging.

BACKGROUND

Adherence to prescribed medication regimen is central to achievingintended health outcome. However, it is well known in the industry thatadherence is generally poor across various medications. As a result,intended health outcomes are compromised, placing cost on the healthcaresystem for remedial care. By way of example:

-   -   The total direct cost of unintended pregnancy in 2010 is $11B. A        publicly funded birth in 2010 cost $12,770.    -   51% of all U.S. births in 2010 were paid for by public        insurance. Public insurance paid for 68% of the 1.5 million        unplanned births in 2010, compared with 38% of planned birth.    -   These numbers would be as if the U.S. federal and state        governments spent ˜$336 on unintended pregnancies for every        woman aged 15-44.

Women of childbearing age use various forms of birth control, of whichthe oral contraceptive pill (OCP) is a common choice. Poor adherence toOCP regimens is the main cause of unintended pregnancy for women usingOCP.

A common approach to improving medication adherence has been“reminders”. Reminder notifications are typically automated anddelivered in the form of alarms, text message, calls and/or e-mails. Amobile device—usually a smart phone or tablet—running mobile applicationsoftware is often the user interface for receiving such notifications.Alternatively, medication may be placed in a case/vessel/package thatincorporates electronic provisions for tracking adherence and issuingaudio/visual notifications. In some cases, the case/vessel/package maybe wirelessly linked to a mobile device to notify the user on the mobiledevice and on the vessel/package both. Approaches such as the above arecommonly referred to as “smart packaging”.

SUMMARY

The present disclosure teaches systems and methods that facilitatetracking of adherence to medicine regimens, such as medicineprescription regimens, through connected, smart packaging. Embodimentsin accordance with the present disclosure are particularly well suitedfor use with blister cards having a forming film in which a plurality ofblisters is formed and an electrically conductive lidding film, wherethe blisters and lidding film collectively define a plurality ofreservoirs for holding one or more tablets. Each reservoir is defined bya blister formed in the forming film and a dispensing region thatincludes a portion of the lidding film.

An illustrative embodiment is a modular smart case that includes anelectronics module and a detection module. The detection modulecomprises a housing having a receiver for removably locating a blistercard in a first position in which its lidding film is held against (i) asensor array that includes a substrate having a platen and an array ofthrough-holes and (ii) a seat that includes a plurality of dispenseholes. The tablets of the blister card, the sensors and through-holes ofthe sensor array, and the dispense holes are all arranged in the samearrangement. The receiver locates the blister card such that eachreservoir of the blister card is aligned with a different sensor anddispense hole. The receiver includes a plurality of electricalconnectors that electrically couple, resistively or capacitively, withthe lidding film of the blister card to electrically ground the liddingfilm and confirm that it is located in the receiver.

Each sensor of the sensor array includes a pair of electrical contactsthat are located on either side of its respective through-hole andconfigured to electrically couple with the lidding film. The electricalcontact are configured to measure the impedance across the dispensingregion of its respective reservoir. When the tablet is dispensed fromthe reservoir, the dispensing region is ruptured, thereby changing theimpedance measured by the contacts of the sensor with which it isoperatively coupled.

The through-hole of each sensor includes a serration that is configuredto facilitate the breakage of the lidding film near it when force isapplied to its respective tablet from the blister side. In someembodiments, the serration is a continuous “blade” that surrounds theperiphery of the dispense hole. In some embodiments, the serrationincludes one or more substantially discrete tips that are dimensionedand arranged to concentrate the applied force within a smaller area ofthe lidding film to initiate its puncture. Preferably, a serration inaccordance with the present disclosure has a low profile to mitigate therisk of injury to a user during a dispensing operation.

In some embodiments, a plurality of connectors is distributed around theperimeter of a region of the blister card such that, when the blistercard is in the first position, the state of the region is determinedusing electrical impedance tomography.

In some embodiments, the plurality of connectors are configured aselectrodes used to electrically couple with the lidding film is locatedon the platen. In some embodiments, the plurality of electrodes isdistributed between the receiver and the seat.

An embodiment of the present invention is a smart case (100) formonitoring the state of a blister card (126) that includes a formingfilm (130), a lidding film (132) that includes a first region (142) thatis electrically conductive and unpatterned and includes a plurality ofdispensing regions (138) within the first region, and a plurality oftablets (128) contained in a plurality of reservoirs (136) that isarranged in a first arrangement, each reservoir being defined by theforming film and a different dispensing region of the plurality thereof,wherein the case comprises: (1) an electronics module (102); and (2) adetection module (104) that includes: (i) a housing (302) having a lid(318) and a body (316), wherein the lid is movable relative to the body;and (ii) a receiver (116) that includes a frame (304), a seat (306), anda plurality of connectors (336) that are electrically connected with theelectronics module when the electronics module and detection module areoperatively coupled, the receiver being configured to removably locatethe blister card such that the lidding film and connectors areelectrically coupled; wherein the electronics module includes electroniccircuitry (112) that is configured to measure a first impedance acrossat least a portion of the first region when the blister card is locatedin the receiver.

Another embodiment of the present invention is a method for monitoringthe state of a blister card (126) that includes a forming film (130), alidding film (132) that includes a first region (142) that iselectrically conductive and unpatterned and includes a plurality ofdispensing regions (138) within the first region, and a plurality oftablets (128) contained in a plurality of reservoirs (136) that isarranged in a first arrangement, each reservoir being defined by theforming film and a different dispensing region of the plurality thereof,wherein the method comprises: (1) locating a blister card in a receiver(116) that includes a frame (304), a body (316), and a plurality ofconnectors (336), wherein the blister card is located in the receiversuch that each connector of the plurality thereof is electricallycoupled with the lidding film; (2) measuring a first impedance across atleast a portion of the first region; and (3) transmitting a statussignal (122) that is based on the measured first impedance.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A depicts a functional block diagram of a modular medicine case inaccordance with an illustrative embodiment in accordance with thepresent disclosure.

FIG. 1B depicts a schematic drawing of a perspective view of a blistercard in accordance with the illustrative embodiment.

FIG. 1C depicts a schematic drawing of a cross-sectional view of onetablet region of blister card 126.

FIGS. 1D-E depict plan view schematic drawings of the front(forming-film side) and back (lidding-film side) of blister card 126.

FIG. 2 depicts a schematic drawing of an electronics module inaccordance with the illustrative embodiment.

FIGS. 3A-B depict schematic drawings of perspective views from the topand bottom sides of a detection module in accordance with theillustrative embodiment.

FIG. 3C depicts a schematic drawing of a perspective view of smart case100.

FIG. 3D depicts a side view of a representative connector 336 engagedwith blister card 126.

FIG. 4 depicts operations of a method suitable for monitoring the stateof a blister card in accordance with the illustrative embodiment.

FIG. 5 depicts a schematic drawing of a top view of a sensor array inaccordance with the illustrative embodiment.

FIGS. 6A-B depict schematic drawings of top and cross-sectional views,respectively, of a representative impedance sensor in accordance withthe illustrative embodiment.

FIG. 6C depicts a case bottom that includes a divided dispense hole inaccordance with an alternative embodiment of the present disclosure.

FIG. 6D depicts a cross-sectional view of an alternative sensor inaccordance with the present disclosure.

FIG. 7 depicts a schematic drawing of a non-modular smart case thatincludes a stylus for applying force to a blister of a blister card.

FIG. 8 depicts a schematic drawing of a top view of an example of analternative serration in accordance with the present disclosure.

FIGS. 9A-C depict schematic drawings of top views of alternativearrangements of contact points in accordance with the presentdisclosure.

FIG. 10 depicts a schematic drawing of a cross-section of a sensor arrayconfigured to monitor the state of a blister card via electricalimpedance tomography.

FIG. 11 depicts a schematic drawing of a top view of an alternativesmart case in accordance with the present disclosure.

FIG. 12A depicts a schematic drawing of a perspective view of analternative smart case that is configured for monitoring the contents ofa single, large-area reservoir content compartment in accordance withthe present disclosure.

FIG. 12B depicts a schematic drawing of a top view of an alternativecontent compartment in accordance with the present disclosure.

FIG. 13A depicts a schematic drawing of a perspective view of anotheralternative smart case that is configured for monitoring the contents ofa single, large-area reservoir content compartment in accordance withthe present disclosure.

FIG. 13B depicts a schematic drawing of a perspective view of yetanother alternative smart case that is configured for monitoring thecontents of a single, large-area reservoir content compartment inaccordance with the present disclosure.

FIG. 14 depicts a schematic drawing of a cross-sectional view of analternative content compartment in accordance with the presentdisclosure.

FIGS. 15A-B depict schematic drawings of cross-sectional and top views,respectively, of portions of an alternative content compartment thatcomprises check valves in accordance with the present disclosure.

DETAILED DESCRIPTION

It should be noted that, although embodiments in accordance with thepresent disclosure are described herein with respect to OCP as anexemplary application, concepts of the present disclosure are applicableto a wide range of other applications; therefore, the use of OCP shouldnot be viewed as limiting the scope of the utility of the conceptsdescribed herein. Other examples of applications in which the smartpackaging concepts of the present disclosure can be used include,without limitation, other forms of medication, non-medication products(e.g., vitamins, supplements, etc.), foodstuff, gum, beverages, toiletryand beauty care products, razor blades, consumer electronics, tonercartridges, toys, tools, etc. In other words, the teachings of thepresent disclosure are applicable to myriad product-trackingapplications. In this Specification, “tablet” and “pill” are usedinterchangeably and are intended to include various form factors, sizesand compositions.

FIG. 1A depicts a functional block diagram of a modular medicine case inaccordance with an illustrative embodiment in accordance with thepresent disclosure. Case 100 includes electronics module 102, detectionmodule 104, and universal interface 134. for joining the electronics anddetection modules. Universal interface 132 includes electrical interface106, mechanical interface 108, and latch 110. Case 100 is a modularsmart case for tracking the state of blister card 126, which in thedepicted example, is a 4x7 format OCP blister card. Although case 100 isa modular case that includes separable electronics and detectionmodules, the teachings of the present disclosure are applicable to smartcases having electronics and detection modules that are not separableand the description of a modular case should not be considered limitingto the scope of the appended claims.

FIG. 1B depicts a schematic drawing of a perspective view of a blistercard in accordance with the illustrative embodiment.

FIG. 1C depicts a schematic drawing of a cross-sectional view of onetablet region of the blister card shown in FIG. 1B. The cross-sectionalview shown in FIG. 1C is through line a-a of FIG. 1B.

FIGS. 1D-E depict plan view schematic drawings of the front(forming-film side) and back (lidding-film side) of blister card 126.

Blister card 126 includes a plurality of tablets 128, each of which iscontained within reservoir 136. Reservoir 136 is formed by blister 140of forming film 130 and dispensing region 138. Dispensing region 138 isthe region of lidding film 132 that forms the bottom of reservoir 136and is the lidding-film portion through which tablet 128 is pushed whenit is dispensed. Each dispensing region 138 is characterized by DRcircumference 142, which is defined by the annulus at which itsrespective blister 140 is joined with lidding film 132. In someembodiments, case 100 is configured to operate with a blister card inwhich at least one reservoir 136 includes a plurality of tablets 128.

Forming film 130 is a layer of thermoformed plastic in which cavitiesfor holding tablets 128 are formed.

Lidding film 132 is a thin sheet of aluminum foil. In some embodiments,lidding film 132 is a sheet of another electrically conductive material.In some embodiments, lidding film 132 includes a sheet of conductivematerial and a sheet of electrically insulating material, such as apaper sheet (with a printed calendar or instructions), polymer, etc. onthe bottom side of the lidding film and/or sandwiched between thelidding and forming films. After tablets 128 are dispensed into thecavities of forming film 130, lidding film 132 is joined with theforming film 130 to seal the cavities, thereby forming reservoirs 136,which enclose tablets 128. Typically, a calendar that describes the drugregimen is printed on the card and/or otherwise provided as part of theblister card.

Blister card 126 includes optional perforation lines 144, which areincorporated to facilitate tearing off a segment of the cardcorresponding to a dose. As a result, each time a dose is dispensed, theuser can discard the corresponding segment of the blister card.

Blister card 126 also includes optional labeling 146 for providingdosing regimen information directly on the back of the blister card. Insome cases, labeling 146 includes other information, such as a calendarthat denotes the drug regimen, manufacturing information (date, lotnumber, etc.), and the like.

It is an aspect of the present disclosure that the teachings herein aresuitable for use with any blister card whose lidding film 132 isunpatterned (i.e., has not been patterned to define electricallyconductive traces). In other words, before any of tablets 128 have beendispensed, the electrically conductive material of lidding film 132 ofblister card 126 exists everywhere within two-dimensional region 142.

The portion of lidding film 132 that seals each cavity to form areservoir defines dispensing region 138, through which its respectivetablet 128 is dispensed by pushing the tablet through the lidding foil.

One skilled in the art will recognize that many types of medication andnon-medication (e.g., vitamins, supplements, etc.) are offered in a formsuitable for packaging in a blister card, such as tablets, capsules,lozenges, etc. For the purposes of this Specification, including theappended claims, the term “tablet” is used as a general term thatencompasses all such medicinal and non-medicinal forms.

FIG. 2 depicts a schematic drawing of an electronics module inaccordance with the illustrative embodiment. Electronics module 102includes housing 202, electronic circuitry 112, communications circuitry114, socket 204, ports 206, and catches 208.

Housing 202 is a conventional molded plastic housing configured toenclose electronics circuitry 112 and communications circuitry 114 in asubstantially environmentally sealed environment.

Electronic circuitry 112 includes controller 210, memory 212, sensorcircuit 214, power circuit 216, display circuit 218, and sleep-modecircuitry 220. The circuitry included in electronics circuitry 112enable it to interface with the sensor array included in detectionmodule 104, as well as receive and condition the output signals of eachsensor (e.g., provide pre-amplification, digitization, etc.), providepower conditioning and management, display information to the user, etc.

Controller 210 is a conventional processor having signal processing andcomputation capabilities.

Memory 212 is a conventional memory module for storing information anddata.

Sensor circuit 214 is configured to receive sensor signals from thesensor array of detection module 104 via electrical interface 106,measure the sensor signals to detect changes in the state of a blistercard held in the detection module, and the like.

Power circuit 216 includes an energy-storage unit and power managementcircuitry. In the depicted example, the energy-storage unit is arechargeable battery; however, a different energy-storage unit can beused in power circuit 216 without departing from the scope of thepresent disclosure. Energy-storage units suitable for use in embodimentsin accordance with the present disclosure include, without limitation,non-rechargeable batteries, super capacitors, and the like. In someembodiments, power circuit 216 includes one or more energy-scavengingdevices (e.g., solar cells, vibration harvesters, etc.) for passivelyrecharging the energy-storage unit.

Display circuit 218 includes a status indicator and drive circuitry forthe status indicator. In the depicted example, the status indicators arelight-emitting diodes (LED); however, other status indicators, such asliquid-crystal displays, LED-based displays, speakers, buzzers, and thelike, can be used in display circuit 218 without departing from thescope of the present disclosure.

Display circuit 218 includes an LED for each row and column of pills tosignal their respective row and column, where the LEDs illuminate (orblink) to indicate the respective row and column from which the pillshould be dispensed. In some embodiments, each row and column have apair of LEDs of different colors that guide the user to the correcttablet by turning on (or blinking) the respective LED of a first color,while cautioning the user against the other tablets by turning on (orblinking) the LEDs of the other color. In some embodiments, row/columnaddressing LEDs are located at the periphery of the blister card withindetection module 104. In some embodiments, each tablet site is providedits own dedicated LED or LED pair.

In some embodiments, display circuit 218 includes provisions for userfeedback to, for example, correlate a patient's health status and theneed for the medication in the content compartment of smart case 100. Insome embodiments, a status indicator is binary (e.g., good or bad). Insome embodiments, a status indicator is more nuanced (e.g., good, fair,poor or bad). Typically, status feedback is generated via user-actuatedbuttons located on the case. In some embodiments, a touch screen displayis incorporated in smart case 100 to enable communication of informationto the user.

Sleep-mode circuitry 220 includes low-power dissipation circuitry, awake-up circuit, and a low-power-dissipation accelerometer. Sleep-modecircuitry 220 facilitates long battery life between charges by enablingan extremely low-power dissipation mode during periods of caseinactivity. Other types of sensors (e.g., touch, plunger switch underthe lid of the case, finger print, radio frequency, etc.) can also beused in realizing a wake-up circuit. In some cases, a combination ofsensors are used for implementing a wake-up circuit. In response to anenvironmental stimulus, such as detection of activity in the case of theaccelerometer (e.g., shock and/or vibration associated with shaking thecase, etc.), a wake-up signal received from external device 120, and thelike, the wake-up circuit activates electronics circuitry 112 such thatit operates in a conventional power-dissipation mode in which it candetermine the state of the blister card located in detection module 104and output its status to the user.

Communications circuitry 114 includes a wireless Bluetooth Low-Energy(BLE) transceiver for sending status signal 122 to external device 120and receiving operational communications 124 from external device 120.In some embodiments, communications circuitry includes a different wiredand/or wireless communications electronics, such as FireWire, USB,lightning connector, a dock connector, cellular, WiFi,near-field-communications (NFC) radio, optical links, etc.

In the depicted example, external device 120 is a smart phone that runsa software application (i.e., a mobile app) that provides assistance tothe patient and/or caregiver to achieve and maintain good adherence tothe prescribed drug regimen. In some embodiments, external device 120 isa different device, such as a different mobile device (e.g., smartwatch, computer tablet, etc.), a computer, a gateway and/or a basestation.

The smart case and smartphone app determine the state of the blistercard and provide a visual and/or audible indication of adherence. Iffailure to follow the regimen is detected, the smartphone contacts oneor more people in the user's defined support group (e.g., a caregiver,spouse, child, doctor, etc.) to alert them that the user might requireassistance.

Socket 204 is a conventional electrical socket that is a first portionof electrical interface 106. Socket 204 is configured to receive a plugdisposed on detection module 104. Once the socket and plug are engaged,electrical communication between electronics circuitry 112 and sensorarray 118 on the detection module is enabled.

Ports 206 are a pair of conventional female mechanical connectors thatcollectively define a first portion of mechanical interface 108. Ports206 are configured to engage a pair of conventional male mechanicalconnectors included in detection module 104. In the depicted example,the ports and male mechanical connectors are configured to enable onlyone orientation between the electronics and detection modules (i.e.,they are “keyed”) to ensure that the modules engage properly.

Catches 208 are mechanical structures that define a first portion oflatch 110. Each of catches 208 is configured to engage a mating springbolt that extend from the mating surface of detection module 104.Catches 208 reversibly lock the two modules together to form a fullyassembled smart medicine case.

It should be noted that the configuration and capabilities ofelectronics module 102 described above is merely exemplary and thatmyriad alternative configurations having more or less electronicsfunctionality can be used for the electronics module without departingfrom the scope of the present disclosure. For example, in someembodiments, electronics module 102 includes, without limitation:

-   -   i. additional processing capability; or    -   ii. onboard clock circuitry; or    -   iii. energy scavenging systems, or    -   iv. alternative or additional sensor interface circuitry; or    -   v. alternative or additional on-case alerts (e.g., LCD displays,        speakers, buzzers, etc.); or    -   vi. environmental (e.g., touch, temperature, acceleration,        humidity, shock, geolocation, etc.) sensors; or    -   vii. any combination of i, ii, iii, iv, v, and vi.

In some embodiments, smart case 100 includes a microphone and/orspeakers, as well as artificial intelligence and machine learningsoftware, such that the smart case is substantially functional as avirtual assistant. In some embodiments, smart case 100 is provisioned toconnect and work with smart speakers to provide virtual assistantfunctionality.

One skilled in the art will recognize, after reading this Specification,that the design features of smart case 100 are based on the particulararrangement of blister card 126, as well as the sensing technology usedto monitor its state and, as provided herein, are merely exemplary.Myriad alternative design features are possible without departing fromthe scope of the present disclosure.

FIGS. 3A-B depict schematic drawings of perspective views from the topand bottom sides of a detection module in accordance with theillustrative embodiment. Detection module 104 includes housing 302,receiver 116, sensor array 118, plug 308, connectors 310, and springbolts 312.

Housing 302 is a conventional molded plastic housing comprising body 316and lid 318, which is typically connected to body 316 via a flexiblehinge portion.

Body 316 comprises seat 306, dispense holes 320, clasp 322, and optionalview port 324.

FIG. 3C depicts a schematic drawing of a perspective view of smart case100. Each dispense hole 320 is aligned with a different sensor of sensorarray 118. FIG. 3C depicts smart case 100 in its assembled state (i.e.,wherein electronics module 102 and detection module 104 are mechanicallyand electrically engaged). It should be noted that, for clarity, neithersensor array 118 nor frame 304 is shown in FIG. 3C.

The arrangement of dispense holes 320 matches that of the arrangement oftablets in blister card 126, thereby enabling each dispense hole to passa different tablet 128 through body 316 when that tablet is dispensed.

View port 324 is an opening formed in body 316 to expose a portion ofblister card 126 for viewing. View port 324 is optionally included toenable information printed on a blister card (such as a bar code, etc.)to be read through housing 302.

Lid 318 is a substantially rigid “clam shell” structure that includescatch 326, which engages clasp 322 when lid 318 is closed to hold thebody and lid together.

FIG. 4 depicts operations of a method suitable for monitoring the stateof a blister card in accordance with the illustrative embodiment. Method400 is described herein with continuing reference to FIGS. 3A-C, as wellas reference to FIGS. 3D, 4, 5, and 6A-B. Method 400 begins withoperation 401, wherein blister card 126 is loaded into receiver 116.

Receiver 116 includes frame 304, seat 306, sensor array 118, andconnectors 336-1 through 336-3.

Frame 304 and seat 306 are collectively configured to locate sensorarray 118 and hold blister card 126 such that each tablet location ofthe blister card is operatively coupled with a different sensor of thesensor array and a different hole of dispense holes 320.

Frame 304 is a substantially rigid plate comprising apertures 328, eachof which exposes a different tablet of the blister card when the frameis locked in place. Frame 304 is connected to body 316 via conventionalhinges 330, which allow the frame to rotate out of the way to enableinstallation of a blister card in the detection module and rotate backover the blister card to engage with a catch (not shown) that securesthe frame and blister card to body 316. In some embodiments, frame 304includes ribs between the rows and or columns of apertures to enhancethe rigidity of the frame. In some of these embodiments, the ribsproject downward toward sensor array 118, which resides on seat 306 suchthat they help force blister card 126 against the sensor array when theframe is engaged with its corresponding catch. It should be noted thatlid 318 and hinges 330 are configured to avoid mechanical interferencebetween them.

Seat 306 is a recessed region of body 316 that is configured to acceptsensor array 118 and blister card 126 and laterally position the blistercard to align its tablets with the sensors and through-holes of sensorarray 118, as well as dispense holes 320. In some embodiments, seat 306is not included. In some embodiments, seat 306 is formed as part offrame 304. In some embodiments, the alignment functionality of seat 306is realized via raised features placed at the perimeter of the blistercard, rather than a full perimeter frame. In some embodiments, sensorarray 118 includes raised features for laterally positioning a blistercard.

In order to ensure good electrical coupling/contact between lidding film132 and sensor array 118, a good mechanical contact between the blistercard and the surface on which it rests is needed. In some embodiments,the inside surface of the lid of the case incorporates a compressibleliner that exerts downward pressure on the blister card when the case isclosed to accomplish a good mechanical contact. An added benefit of sucha liner is that the card is immobilized in place when the lid is closed.Such a compressible liner can comprise any of a variety of materials,such as foam, sponge, bubble wrap, spring-load plates, and the like.Preferably, the liner is attached to the inside surface of the lid, butcan also be used without such attachment—like a cushion or a packing.

At operation 402, electrical contact is established between lidding film132 and each of connectors 336-1 through 336-3.

FIG. 3D depicts a side view of a representative connector 336 engagedwith blister card 126. Each of connectors 336-1 through 336-3 (referredto, collectively, as connectors 336) is a conventional “leaf-spring”wiper contact that includes spring portion 340, base portion 342, andoptional projection 344.

Connectors 336 are configured to enable insertion of an edge of blistercard 126 between spring portion 340 and base portion 342. Each of theconnectors 336-1 through 336-3 is configured such that spring portion340 exerts a downward force on the blister card that helps keep theblister card in place and also facilitates good electrical contactbetween the connector and lidding film 132. In the depicted example,connectors 336 include optional projection 344, which concentrates theforce applied by spring portion 340 between projection 344 and thelidding film.

In the depicted example, seat 306 includes optional recess 338, which isconfigured to mount connectors 336-1 through 336-3 such that the top ofthe base portion of each connector—housed in recess 338—is substantiallyflush with the top surface of seat 306.

Although in the illustrative embodiment connectors 336 are leaf-springconnectors, it should be noted that myriad alternative connectors can beused to provide good mechanical and electrical coupling/contact withlidding film 132 without departing from the scope of the presentdisclosure. For example, in some embodiments, at least one of connectors336 is a clamp-like connector. Furthermore, in some embodiments, atleast some of the functionality of connectors 336-1 through 336-3 isrealized via contacts disposed on the surface on which the lidding filmrests.

In the depicted example, connectors 336 are electrically connected toelectronic circuitry 112 such that connector 336-2 is electricallyconnected to ground. As a result, when blister card 126 is inserted intodetection module 104, lidding film 132 is electrically grounded. Inaddition, electronic circuitry 112 measures the resistance betweenconnectors 336-1 and 336-3. Detection of a non-infinite resistancebetween connectors 336-1 and 336-3 confirms that blister card 126 isinserted into the detection module.

As discussed below, in some embodiments, connectors 336 are not indirect physical contact with lidding film 132 due to an interveninginsulating layer. In such cases, connectors 336 are capacitively coupledwith the lidding film and the electrical impedance is measured betweenconnectors 336-1 and 336-3 to establish whether blister card 126 isinserted into the detection module. For the purposes of thisSpecification, including the appended claims, the terms “impedance” and“resistance” are used interchangeably.

In some embodiments, connectors 336-1 and 336-3 are locally connected toelectronic circuitry located within detector module 104 itself.

In addition, in some embodiments, connectors 336 also guide theplacement of blister card 126 in case 100, where the blister card isinserted into the clips by sliding it under the clips.

Exemplary smart case 100 also includes optional microcamera 346 andbiosensor 348.

At operation 403, user authentication is performed by taking an image ofthe user via microcamera 346 and comparing the acquired image with oneor more authorized-user images stored in memory 212. In someembodiments, user authentication is performed via a finger-print sensorinstead of, or in addition to, microcamera 346.

If user authentication fails, method 400 proceeds with operation 404A,wherein an alert is generated. In the depicted example, the alert isgenerated as an audible alarm emitted by a speaker located on the case(not shown). In some embodiments, the alert includes a message sent to acorresponding app on the user's phone, and/or through an e-mail to theuser, or someone designated by the user, and the like. Typically, such amessage includes the time and/or case location when the lid was opened,what tablet was dispensed, etc., which is also stored in memory 212 forfuture synching with the phone/network if (wireless) connection is notavailable at the time.

If user authentication succeeds, at least one of catch 326 and clasp 322is electrically actuated to release lid 318 from body 316 therebyenabling smart case 100 to be opened. It should be noted that the use ofelectrically actuated catches and/or clasps are optional; however,preventing smart case 100 from being opened without properauthentication provides real-time safeguards against unauthorized accessto the content compartment.

At optional operation 405, a health assessment of the user is performed.Such an assessment is performed via biosensor 348 and/or sensors 350.

Biosensors 348 are conventional multi-electrode touch sensors suitablefor measuring a user parameter, such as bio-impedance and/orbio-potential measurements. For example, the user may touch (e.g., withhis/her index fingers) two electrodes for a one-lead electrocardiogram(ECG) measurement. In some embodiments, three or more electrodes aredisposed on electronics module 102 to enable a more comprehensive ECGmeasurement, for example: monitor outcome along with adherence for heartdisease patients using a smart pill case for heart disease medication;monitor side effects and/or interactions of OCP or other medications theuser is taking in addition to the prescribed medication, and the like.

Sensors 350 include environmental sensors, such as gas sensors, whichenable, among other things: to monitor environmental constituents andcorrelate them to the health and wellness conditions of the user; breathanalysis (alone or in combination with humidity and temperature sensors)to monitor bad, cigarette and alcohol constituents, disease states, etc.Sensor data can be used to, for example: to alert the user to dispense abreath mint or piece of gum from the content compartment if halitosis isdetected; warn the user to delay taking medication when an improperalcohol content of the breath is detected; warn the user thatenvironmental factors (e.g., temperature, humidity, air quality, etc.)are potentially dangerous for patients with respiratory sensitivitiesand diseases and alert the user to take his/her corresponding medicationin the content compartment and correlate the corresponding environmentalfactors that trigger the need for a dose, and the like.

It should be noted that touch- and gas-sensor data can be used inassociation with medicinal or non-medicinal use of smart case 100. Forexample, a smart case used to hold blister-packaged gum can beconfigured to alert the user when sensor data indicates a condition,such as bad breath (e.g., due to food consumption, cigarette use,alcohol consumption, etc.), that can be mitigated by taking a piece ofgum from the smart case. Furthermore, tracking the sensor data andactions can help a user better address related concerns.

In some embodiments, one or more gas sensors are incorporated within oneor both of electronics module 102 and detection module 104 such that theuser uses the sensors by blowing onto a port that is fluidically coupledwith the sensors. An ultraviolet radiation sensor on a case placed nextto a user can for example be used to alert the user to apply sunblockfrom the content compartment of the case. It should be noted that healthassessment of a user, as described above, is applicable for use withother containers, such as pill bottles, multi-tablet blister cards, andthe like. Examples of containers for which user health assessment isparticularly well suited are described in such as those described inU.S. patent application Ser. Nos. 14/879,874, filed Oct. 9, 2015(Attorney Docket: 3005-002US1), 15/170,121, filed Jun. 1, 2016 (AttorneyDocket: 3005-002US2), 15/223,779, filed Jul. 29, 2016 (Attorney Docket:3005-004US1), and U.S. Provisional Patent Applications Ser. Nos.62/062,291 filed on Oct. 10, 2014 (Attorney Docket: 3005-002PR1),62/320,234 filed on Mar. 25, 2016 (Attorney Docket: 3005-003PR1), and62/320,234 filed on Apr. 8, 2016 (Attorney Docket: 3005-004PR1), each ofwhich is incorporated herein by reference.

At operation 406, the opening of lid 318 is registered and stored inmemory 212. The opening of lid 318 is sensed by an electrical plungerswitch (not shown), which is mechanically coupled with the lid.Triggering of the switch typically initiates several actions, such asrecording date, time and duration. In some embodiments, the opening oflid 318 initiates a wakeup circuit is included to reduce powerconsumption when the case is not in use. Wakeup circuits in accordancewith the present disclosure can include, without limitation,accelerometers, touch circuits, etc.

At operation 407, sensor array 118 determines the state of eachdispensing region 138 of lidding film 132.

FIG. 5 depicts a schematic drawing of a top view of a sensor array inaccordance with the illustrative embodiment. Sensor array 118 (not shownin FIGS. 3A-C) comprises substrate 502, sensors 504-1 through 504-28,and through-holes 506. Each of the pluralities of sensors andthrough-holes is arranged in the same arrangement as tablets 128 anddispense holes 320.

FIGS. 6A-B depict schematic drawings of top and cross-sectional views,respectively, of a representative impedance sensor in accordance withthe illustrative embodiment. Sensor 504 is representative of each ofsensors 504-1 through 504-28. FIG. 6B depicts sensor 504 as operativelycoupled with blister card 126.

Substrate 502 is a substrate suitable for supporting the fabrication ofsensors 504-1 through 504-28 (referred to, collectively, as sensors504). In the depicted example, substrate 502 is a conventional,multi-layer printed-circuit board (PCB). In some embodiments, substrate502 is a different substrate, such as a semiconductor substrate, ceramicsubstrate, plate of composite material, and the like. In someembodiments, substrate 502 comprises a flexible material or isincorporated into a different surface of case 100 (e.g., its lid, backsurface, etc.) by, for example, embedding components into the materialof housing 302, printing electronic elements on the surface itself, andthe like. In some embodiments, substrate 502 is incorporated into frame304. In some embodiments, sensor array 118 is incorporated into lid 318such that sensors 504 are capacitively coupled with lidding film 132through forming film 130 when the lid is closed. In the latter twoexamples, electrical interconnections to substrate 502 accommodatehinged operation of the mechanical component.

The top surface of substrate 502 (i.e., platen 508) functions as a hardsurface against which blister card 126 rests. As such, sensor array 118resides between seat 306 and blister card 126 such that each of sensors504 is operatively coupled with a different dispensing region 138 oflidding film 132 when the blister card is secured by receiver 116. Insome embodiments, sensor array 118 is integrated into seat 306 (i.e.,seat 306 also serves as substrate 502).

Each of sensors 504 is an impedance sensor comprising metal tracesformed on platen 508. The metal traces terminate at through-hole 506 todefine contact points 604A and 604B.

Through-holes 506 are apertures formed through the thickness ofsubstrate 502 to allow for the passage of tablets 128 through detectionmodule 104 when dispensed from blister card 126.

It should be noted that, in the prior art, the lateral stresses thatmanifest at lidding-film 132 when a blister is being pushed (to dispensea tablet) are relatively low compared to the fracture stress of thelidding film. As a result, the lidding film can deform substantiallybefore any rupture occurs and the magnitude of force that must beapplied by the user to induce rupture of the lidding film can besignificant. Accordingly, it can be difficult for some users to dispensea tablet from a blister card. This challenge can be particularly acutefor some senior citizens, those on other medications (e.g., diabetes,cholesterol, hypertension, etc.), as well as many others.

It is an aspect of the present disclosure, however, that dispensing aproduct from a blister card can be made easier by concentrating theforce applied to a blister into larger localized lateral stresses in thelidding film to initiate fracture. This stress concentration is achievedby including serrations 510 at the inside edge of through-holes 506.

In the depicted example, each serration 510 includes ramp 606, whichprojects upward from platen 508 to form a continuous sharp edge (i.e.,tip 608) around the perimeter of each through-hole.

When force F is applied to tablet 128 through blister 140 (e.g., using afinger, a stylus, etc.), lidding film 132 is pressed against serration510. This concentrates the force applied to the relatively larger areaof blister 140 and tablet 128 at tip 608, which has a relatively smallerarea (i.e., pressure region 614). As a result, pressure, S, at liddingfilm 132 is magnified and easily initiates fracture of lidding film 132in pressure regions 614. As a result, the magnitude of force F requiredto initiate fracture of lidding film 306 can be much lower than neededin the prior art.

In some embodiments, at least one of the geometry, number, distribution,and location of serration 510 is defined to effect a desired liddingfilm fracture at a predetermined magnitude of force F and/or subsequentfracture/tear propagation path. In some embodiments, serration 510 isdiscontinuous around the perimeter of through-hole 506. In someembodiments, serration 510 has an upper edge that has undulations and/ordiscrete sharp features that concentrate the applied force into smallerareas of the lidding film.

Typically, the configuration of ramp 606 is selected to providesufficient cutting capability without sacrificing strength. In someembodiments, ramp 606 is configured such that it creates a stressconcentration in lidding film 132 that provides efficient cutting actionwhile also mitigating the potential for injury to the finger of a useras tablet 128 is pushed through the lidding film.

In some embodiments, tip 608 is analogous to the sharp edge of adifferent cutting element, such as a serrated knife, a saw blade, andthe like, or any combination thereof. In other words, in someembodiments, tip 608 includes features having one or more of puncturingand cutting geometries and arrangements used in knives, blades,puncturing tools, and the like. In some embodiments, serration 510 haselements distributed radially from the through-hole 506.

FIG. 6C depicts a case bottom that includes a divided dispense hole inaccordance with an alternative embodiment of the present disclosure.Case bottom 616 includes platen 618, dispense hole 620, and serration622.

In the depicted example, serration 622 is analogous to serration 510described above; however, serration 622 includes portions that arelocated around the peripheries of each of the divisions of dispense hole620.

It should be noted that, in some embodiments, dispense hole 620 issingular (i.e., without divisions) even when a blister site containsmore than one tablet.

FIG. 6D depicts a cross-sectional view of an alternative sensor inaccordance with the present disclosure. Sensor 624 is a capacitivesensor whose output signal is based on the state of dispensing region138. Sensor 624 includes contacts 602A and 6026, electrode 626, andelectrode 628. Sensor 624 is analogous to high-noise-immunity capacitivesensors described in U.S. patent application Ser. No. 15/223,779.

Each of electrodes 626 and 628 is formed within substrate 502 such thatit is a planar, circular metal electrode that completely surroundsthrough-hole 506 and is parallel with platen 508. Electrodes 626 and 628are formed such that electrode 626 is between lidding film 132 andelectrode 628 when blister card 126 is located in receiver 116. In thisstate, electrode 626 and dispensing region 138 collectively define acapacitor whose capacitance defines the output signal of sensor 624,where the value of its capacitance is based on the state of dispensingregion 138.

Contacts 602A and 602B are electrically connected to ground throughtraces 610 (not shown). As a result, when the blister card is located inthe receiver, lidding film 132 is grounded and functions as a groundplane that mitigates the effects of noise and interference on the sensorthat originates from the top side of blister card 126. For the purposesof this Specification, including the appended claims, an “electricalshield” is defined as an element that mitigates the effects of straycapacitance, electrical noise, and electrical interference on anelectrical parameter measured at another element. It should be notedthat sensor 624 can include any practical number of contacts 602 (e.g.,one, three, ten, etc.) without departing from the scope of the presentdisclosure.

In the depicted example, electrode 628 is also electrically connected toground and, therefore, functions as a ground plane that defines anotherelectrical shield, which mitigates the effects of noise and interferenceon the sensor that originates from the bottom side of blister card 126.

In some embodiments, in order to further mitigate the effects of noiseand interference, at least one of electrodes 626 and 628 is segmentedinto a pair of half-rings. In some embodiments, at least one ofelectrodes 626 and 628 is segmented into more than two circumferentialsections. In some embodiments, an electrically grounded shield line isformed in the plane of electrode 626, where the shield linesubstantially surrounds the electrode, thereby functioning as a thirdelectrical shield that mitigates the effects of laterally directed noiseand interference on the sensor.

It should be noted that the blister plastic and the lidding aluminumfilms have very different material and structural properties. Theblister is far more resistant to puncture and tear than the liddingfilm. Typically, therefore, serrations can be designed to puncture andtear the lidding film without significantly damaging the blister, whichenables a user to safely push a pill through its blister without riskinginjury to their fingers.

At operation 408, electronics module 102 transmits status signal 122 toexternal device 120. Status signal 122 includes the status of dispensingregions 138, as well as the date and time at which smart case 100 wasopened. In some cases, status signal 122 includes an indication of achange in one or more of the dispensing regions from their condition atthe most recent previous determination of their states. If the externaldevice 120 is not in range, the status signal is stored in memory 212and transmitted to external device 120 at some point in the future whenexternal device 120 is in range.

In some embodiments, a stylus for applying force to a blister isincluded to further ease the process of dispensing a tablet.

FIG. 7 depicts a schematic drawing of a non-modular smart case thatincludes a stylus for applying force to a blister of a blister card.Case 700 is analogous to case 100; however, case 700 includes stylus 702and stylus holder 704, which holds stylus 702 in the case when it is notin use.

FIG. 8 depicts a schematic drawing of a top view of an example of analternative serration in accordance with the present disclosure.Serration 800 includes a plurality of discrete tips 802, which arearranged around the perimeter of through-hole 506.

Each of tips 802 is a sharp projection that concentrates puncturestresses into smaller regions of lidding film 132. One skilled in theart will recognize, after reading this Specification, that tips 802 canhave myriad configurations over one or more similar or differingarc-segments of the periphery of through-hole 506. For example,including only one tip 802 at the periphery of through-hole 506 willgive rise to the lidding film being punctured at its location, wheretearing of lidding film 132 will initiate. Discrete serrations, such asserration 800, can also incorporate puncturing and cutting geometriesand arrangements used in knives, blades, puncturing tools, and the like.

It should be noted that puncturing of the lidding film can be initiatedat one or more locations and the subsequent tearing of the lidding filmcan then be guided through relative placement of other tips 802 along anarc or (extrapolated) radius of through-hole 506 periphery. For example,a single point of puncture by an individual cone- or pyramid-shapedserration tip can be located at the periphery of through-hole 506, whileadditional, shorter serration tips can be located to one or the other(or both) side(s) of the individual tip over a desired arc length. Thetaller individual point will effect puncture of the lidding film aspressure/force is applied to blister 140. After this initial puncture,the remaining shorter serrations will give rise to tearing of thelidding film in their direction.

Furthermore, serration tips may be placed in locations that are locatedradially away from the periphery of through-hole 506, including incombination with others at the periphery of through-hole 506. Suchdesign flexibility enables additional degrees of freedom in initiatingand propagating tearing of the lidding film. By way of example, a ringof serrations placed away from through-hole 506 periphery—but stillunder the blister site's lidding film membrane when the through-hole 506is smaller than dispensing region 138 but large enough to allow tablets128 through—will result in tearing of a larger area of lidding film 132.

Alternatively, serration tips can be located at radially opposite sidesof a through hole such that the serrations radially emanate away fromthe through hole, which will drive tearing of the lidding film along theline along the opposing radial serrations. By moving the opposing radialserrations off center with respect to the through-hole's center, thetear across will move off center correspondingly.

One skilled in the art will recognize, after reading this Specification,that myriad combinations of geometry, number, distribution, and locationof serration tips and/or serrations exist for driving specific goals ininitiating and propagation tearing of the lidding film. Furthermore,serrations/tips located at the periphery of a dispense hole may befabricated in the plane of the hole or at any angle to it. There arealso myriad of ways to fabricate these serrations, including from hardplastics, glass, metal, ceramic, and the like. For example, theserrations may be realized as part of the fabrication of the surface ofseat 306 on which the blister card rests. This surface may be the insidesurface of the bottom structure of the smart case itself, when thisbottom structure also incorporates the sensing provisions.Alternatively, the serrations may be fabricated as part of a separatesurface upon which the blister card rests—with this new surface restingon seat 306 or a PCB incorporating the sensing provisions and alsoconstituting seat 306. In some embodiments, the serrations arefabricated onto the surface of a PCB that includes the sensingprovisions and also constitutes platen 508. Alternatively,serrations/tips may be fabricated separately and assembled onto any suchplaten.

Returning now to FIGS. 5-6, sensor 504 includes contacts 602A and 602B,which are metal traces formed on the top surface (i.e., platen 508) ofsubstrate 502. Contacts 602A and 602B terminate at through-hole 506 todefine contact points 604A and 604B, which reside on serration 510.

The state of dispensing region 138 is determined by measuring theresistance between contact points 604A and 604B when they are inphysical and electrical contact with lidding film 132. It should benoted that the increased pressure realized by virtue of serration 510also improves the electrical connection between contact points 604A and604B and lidding film 132.

Electrical connection between contact points 604A and 604B andelectronic circuitry 112 is established by connecting contacts 602A and602B to traces 610 and vias 612, which are metal features formed withinthe body of substrate 502 in conventional fashion.

Although the illustrative embodiment includes sensors that measure theresistance across their respective dispensing regions using two contactpoints, in some embodiments, the impedance of a dispensing region ismeasured using a sensor having a different number of contact points,each of which is electrically connected to measurement electronics(e.g., electronic circuitry 112, located on substrate 502, etc.) viacontacts, vias, and traces, as described above.

FIGS. 9A-C depict schematic drawings of top views of alternativearrangements of contact points in accordance with the presentdisclosure.

Arrangement 900 includes four contacts 902, which terminate atthrough-hole 506 at contact points 904A, 904B, 904C, and 904D.

Contacts 902 are analogous to contacts 602A and 602B described above andare configured such that contact points 904A, 904B, 904C, and 904D aredistributed around through-hole 506 in a substantially squarearrangement. The arrangement of contact points 904A, 904B, 904C, and904D enables four-point probe measurement of dispensing region 138, aswell as other impedance measurement techniques.

In the depicted example, each of contact points 904A, 904B, 904C, and904D is disposed on a tip 906, which are each analogous to tips 702described above.

Arrangement 908 is an alternative contact arrangement that enablessimple impedance measurement of dispensing region 138.

Arrangement 910 is an alternative contact arrangement that enablessimple impedance or, alternatively, four-point probe measurement ofdispensing region 138.

It should be noted that the contact and contact point shapes andarrangements shown in FIGS. 9A-C represent only a few examples ofalternative arrangements of contacts, contact points, and serration tipsin accordance with the present disclosure. The shape, size, number andarrangement of contacts, contact points, and/or serration tips can beselected to realize a wide range of desired sensing sensitivity andreliability, as well as sensing power consumption considerations.

It should be noted that, in some embodiments, blister card 126 includesan electrically insulating layer (e.g., cardboard, plastic, etc.) thatresides over the exposed surface of lidding film 132. In suchembodiments, contacts 602, as well as connectors 336, are not in directphysical and electrical contact with lidding film 132 when blister card126 is located in detection module 104. In such cases, contacts 602 andconnectors 336 are capacitively coupled with the lidding film.

Although sensor array 118 employs impedance-sensing technology tomonitor the state of blister card 126, many alternative sensingtechnologies can be employed in detection module 104 without departingfrom the scope of the present disclosure. Sensing technologies suitablefor use in embodiments in accordance with the present disclosureinclude, without limitation, capacitive sensing, strain sensing, opticalsensing, acoustic sensing, tactile sensing, thermal sensing, andmagnetic sensing, among others.

Furthermore, in some embodiments, the state of a region within liddingfilm 132 is determined by imaging the region via electrical impedancetomography (EIT) rather than simple direct impedance measurement. UsingEIT, the resistance (or impedance) distribution within the region can bedetermined via a plurality of connectors arranged about at least aportion of the periphery of the region.

FIG. 10 depicts a schematic drawing of a cross-section of a sensor arrayconfigured to monitor the state of a blister card via electricalimpedance tomography. Sensor array 1000 includes connectors 1002-1through 1002-10, which are arranged around the perimeter of substrate502. It should be noted that any number and areal distribution (i.e.,distribution over the area of blister card 126) of connectors can beused in sensor array 1000 without departing from the scope of thepresent invention. In some embodiments, sensing of aggregate resistancechanges of the card's lidding film is measured by only have twoconnectors—on opposing sides—to determine if and how many tablets aredispensed.

Each of connectors 1002-1 through 1002-10 (referred to, collectively, asconnectors 1002) is analogous to connectors 336 described above and withrespect to FIGS. 4A-D; however, connectors 1002 are configured to enableinsertion of blister card 126 into seat 306 without significantdeformation of the blister card. In some embodiments, connectors 1002are “zero-insertion-force” (ZIF) connectors that close over the blistercard after it has been inserted.

In some embodiments, connectors 1002 are metal bumps on the surface onwhich blister card 126 rests. In some embodiments, such metal pumps areshaped as needles/probe tips that pierce blister card 126, makingelectrical contact to the blister card's lidding film and, at the sametime, securing the blister card in place mechanically. In suchembodiments, electrical contact to the lidding film would not beaffected by out of plane movement of the blister card. At the same time,the protrusion of needle/probe-like connectors 1002 through thelaterally stiff/tear-resistant forming film secures the blister cardlaterally.

As will be appreciated by one skilled in the art, electrical impedancetomography imaging and electrical resistance tomography (ERT) imaging(a.k.a., electrical resistance imaging (ERI)) are well-known techniquesused for imaging tissue in medical applications, as described byDuraiswami, et al., in “Efficient 2D and 3D EIT using dual reciprocityboundary element techniques,” Engineering Analysis with BoundaryElements, Vol. 22, pp. 13-31 (1998), and elsewhere. In such approaches,a forward model of a system is first developed by modeling the systemfor a plurality of potential configurations of a parameter of interest.These modeled configurations are then stored in a look-up table. Anunknown parameter configuration is then reconstructed by makingmeasurements of the system, whose results are then compared to thosepredicted by the stored models. Typically, an iterative algorithm isused in doing so, identifying features of interest in the measuredsystem.

To develop an image of region 142 of lidding film 132 within using EIT,pair-wise measurements of the impedance between pairs of connectors 1002are made by generating an electric stimulus (in the present example, anelectric current) between a first pair of connectors that serve as thecurrent source and sink. The voltage potential between each other pairof terminals is then measured to determine the potential differencebetween their respective locations. In such embodiments, for a systemwith N terminals there are approximately N⁴ different terminalconfigurations. Such pair-wise measurements are analogous to ERT methodsdescribed by LaBrecque in U.S. Pat. No. 8,733,432 and EIT measurementsdescribed by Duraiswami, et al., in “Efficient 2D and 3D EIT using dualreciprocity boundary element techniques,” each of which is incorporatedherein by reference.

For example, LaBrecque discloses, “. . . in ERT, each measurement usesfour electrodes; one pair of electrodes serves as the current source andsink and a second pair measures the potential difference between twopoints. For a system with N electrodes there are approximately N⁴different configurations referred to as arrays.” In similar fashion,Duraiswami discloses, “In electrical impedance tomography (EIT) thedistribution of impedances inside an object ('image') is sought byapplying specified currents at some electrodes, and performingmeasurements of the voltage at other electrodes. The equations for theelectric field then provide a relationship between the impedancedistribution inside the medium and the measured voltages and appliedcurrents. Different kinds of materials have different impedances, andthe availability of an impedance map provides an image of the materialDistribution.” One skilled in the art will recognize that ERT and EITmeasurements, such as those described by LeBrecque and Duraiswami, aresuitable for use in embodiments of the present invention.

FIG. 11 depicts a schematic drawing of a top view of an alternativesmart case in accordance with the present disclosure. Smart case 1100includes body 1102, frame 1104, connectors 1002-1 through 1002-10, andanchors 1106. Smart case 1100 is depicted as operatively coupled withblister card 126.

Body 1102 is analogous to body 316 described above; however, body 1102is a rectangular annulus having a single central opening that defines asingle dispense hole 1108. Dispense hole 1108 is analogous to eachdispense holes 320 described above. In the depicted example, dispensehole 1108 is large enough to extend completely around region 142 ofblister card 126.

Frame 1104 is analogous to sensor array 118 described above; however,frame 1104 is a rectangular annulus of structural material having asingle central opening (i.e., through-hole 1110) and does not includeindividual sensors at each dispense region of blister card 126. In thedepicted example, through-hole 1110 is the same size as dispense hole1108. As a result, dispensing regions 138-1 through 138-28 (indicated bydashed-line circles) all reside within the perimeter of each of dispensehole 1108 and through-hole 1110.

In some embodiments, at least one of body 1102 and frame 1104 includesribs along the x- and/or y-directions (or other directions) that definea plurality of sub-openings within the central opening of their annuli.Typically, each such sub-opening is large enough to surround more thanone tablet region of blister card 126. As a result, the differentportions of the blister card would be analogous to a plurality of“diaphragms,” each suspended over a different sub-opening.

Each of anchors 1106 is a fastener that holds a different portion ofblister card 126 and disables lateral motion of that portion. In thedepicted example, each anchor 1106 is a pin that pierces both liddingfilm 132 and forming film 130. In some embodiments, at least one ofanchors 1106 is a different type of fastener, such as a screw, a clamp,and the like.

Anchors 1106 mitigate lateral motion and/or buckling of the unsupportedportion of blister card 126 when force is applied to one or moreblisters 140.

It should be noted that, in embodiments wherein body 1102 and/or frame1104 define(s) a plurality of sub-openings, anchors 1106 may beadditionally or exclusively located along the perimeter of each of thesub-openings to affix the edge of each of the “diaphragms” in place.

In some embodiments, the functionality of each of connectors 1004 andanchors 1106 is combined into a single element that both fastens aportion of the blister card in place and makes electrical contact withthe lidding film at the location of the element.

In some embodiments, frame 1104 is not included and connectors 1002 aredisposed directly on body 1102.

In some embodiments, connectors 1004 are disposed on a separatesubstrate that functions as a platen as described above and with respectto substrate 502 of sensor array 118.

In some embodiments, anchors 1106 are located on the surface of body1102 against which blister card 126 rests, piercing through blister card126 from the lidding film side. In some embodiments, anchors 1106 arelocated on the underside surface of frame 1104, piercing through blistercard 126 from the forming film side. In embodiments that include aplaten, anchors 1106 are located on the surface of the platen againstwhich blister card 126 rests, piercing through blister card 126 from thelidding film side.

It should be noted that, in some embodiments, more than one pill isincluded within a single blister site on a blister card.

Accommodating “Peel-Away” Blister Cards

Some blister cards are designed to make them more child proof using amulti-layer lidding film that is more difficult to rupture or tear.Typically, the layers include a metal foil (e.g., aluminum) on theinside, paper on the outside, and a thin polymer layer sandwiched inbetween the metal and paper. Such blister cards are referred to hereinas “peel-away” blister cards. Typically, in a peel-away blister card,peeling the lidding film off is a central step to dispensing thecontents of a blister—rather than pushing the tablet through thecomposite lidding film.

Embodiments in accordance with the present disclosure are suitable foruse with peel-away blister cards, which are typically removed from thecase to facilitate opening the desired blister site to dispense itscontent. Once the content has been dispensed, the blister card isre-inserted into the smart case. It should be noted that, since theblister content is not pushed through the case bottom, inclusion ofdispense holes 320 and through-holes 506 is optional.

In some cases, peel-away blister cards include perforation lines tofacilitate removal of a segment of the card corresponding to a dose.Once a dose portion is separated, the user peels off its lidding film toaccess its blister content. Each time a dose is dispensed, the userdiscards the corresponding segment of the blister card. In other words,the blister sites and their corresponding perforated segments vanishwith each dose—leaving a smaller portion of the card behind.Accordingly, when a user removes the card from the case, separates asegment, and places the remainder of the card in the case, the change inthe card can be detected by the case. In such cases, the separatedsegment may be thought of as an empty blister site void of any liddingfilm.

Accommodating Medication Packages Other Than Blister Cards

One skilled in the art will appreciate that a flat, rectilinear contentcompartment is substantially a special shape of a bottle, vessel, vial,tub, tube, pouch, can, cartridge, and the like. Accordingly, the use ofthe smart case is not limited to blister-card formats and a single largecontent compartment can be used to contain loose pills (of one or moremedicines), liquids, gels, syrups, suspensions, powders, pastes, creams,strips, vapor, spray, and the like. Depending on the electricalproperties of the medication content (e.g., dielectric or conductive),the EIT sensing techniques described above, as well as a variation ofEIT sensing, namely, electrical capacitance tomography (ECT) sensing,can be used to monitor the state of the content.

ECT is used to determine the distribution of the contents of a vessel bymeasuring the related permittivity distribution through the volume ofthe content compartment, which can be used to extract the number and/orshapes/features of a quantity of pills or other material it contains.This enables the addition or removal of pills/material to be monitored,as well as identification of the type of material introduced/removed.The requisite capacitance measurements for ECT are achieved by using aplurality of connectors that surround at least a portion of the volumeto be imaged, as depicted in FIG. 10 above. In some embodiments, aregion to be imaged is surrounded by one or more circumferential sets ofconnectors and the electrical capacitances between all combinations ofthe connectors within each set are measured. This information is thenused to construct an image of the content of the cross section of thevessel enclosed by the connectors, based on variations in thepermittivity of the material inside the vessel.

FIG. 12A depicts a schematic drawing of a perspective view of analternative smart case that is configured for monitoring the contents ofa single, large-area reservoir content compartment in accordance withthe present disclosure. Case 1200 is a non-modular smart case thatincludes housing 1202, electronics module 102, and detection module1204. In some embodiments, case 1200 is modular, as described above andwith respect to case 100.

Detection module 1204 includes content compartment 1206 and sensor array1208.

Content compartment 1206 is a large-area reservoir suitable for holdingcontent 1210 and includes bottom 1212 and four sidewalls 1214. In thedepicted example, bottom 1212 is a substantially flat (i.e., planar)surface.

In the depicted example, content 1210 comprises loose tablets of asingle type of medication; however, in some embodiments, content 1210includes a different medicinal content, such as a plurality of tablettypes (e.g., different medications, different tablet sizes and/orshapes, etc.), gels, liquids, powders, creams, pastes, strips, and thelike. Furthermore, in some embodiments, content compartment 1206 isconfigured to accept a peel-away blister card that contains one or moretablets and/or tablet types. Still further, in some embodiments, contentcompartment 1206 is configured to hold non-medicinal content, such asbreath mints, chewing gum, and/or other product units.

Sensor array 1208 includes a plurality of electrodes 1216, which isarranged such that the electrodes surround around at least a portion ofthe content compartment. In the depicted example, electrodes 1216 areembedded in bottom 1212 and in each of the sidewalls of contentcompartment 1206, which comprise a dielectric material (e.g., plastic,glass, etc.).

In some embodiments, electrodes 1216 are arranged in a differentarrangement about content compartment 1206. For example, in someembodiments, at least some of electrodes 1216 are disposed in or on lid318.

Sensor array 1208 is electrically coupled with electronics module 102such that the interior volume of content compartment 1206 can bemonitored via ECT. ECT is preferably used to monitor materials havinglow electrical conductivity; however, analogous smart cases can also beused to monitor content that is electrically conductive via EITtechniques.

FIG. 12B depicts a schematic drawing of a top view of an alternativecontent compartment in accordance with the present disclosure. Contentcompartment 1218 includes bottom 1220, which is analogous to bottom1212; however, bottom 1220 includes recesses 1222.

Recesses 1222 define features suitable for capturing tablets that havematching size and shape. As a result, tablets can be simply poured intocontent compartment 1218 and shaped recesses 1222 will convenientlyarrange them for the user without requiring them to be carefully placedinto specific sites. In some such embodiments, one or more of theserecesses includes its own sensing provisions, which can encompassvirtually any of the sensing approaches described herein.

FIG. 13A depicts a schematic drawing of a perspective view of anotheralternative smart case that is configured for monitoring the contents ofa single, large-area reservoir content compartment in accordance withthe present disclosure. Case 1300 is analogous to case 1200; however,case 1300 includes detection module 1302, which is configured to monitorthe contents of content compartment 1206 via simple parallel-platecapacitance sensing.

Detection module 1302 includes sensor array 1304, which is operativelycoupled with electronics module 102. Sensor array 1304 compriseselectrodes 1306-1 and 1306-2, which are disposed on bottom 1212 andsurface 1308 of lid 318, respectively.

When lid 318 is closed, electrodes 1306-1 and 1306-2 collectively definea large parallel-plate capacitor whose capacitance is based upon thedielectric constant in the gap between the electrodes (i.e., thecontents of content compartment 1206). Each time content is removed oradded to content compartment 1206, the dielectric constant in the gapformed by the two electrodes changes, giving rise to a capacitancechange related to the change in the content.

In some embodiments, the lid located on the side of the case's contentcompartment. For example, a side-positioned lid is preferable for asmart case configured to accept a pancake-like bottle.

In some embodiments, lid 318 comprises a sliding hinge rather than arotational hinge, includes a cap that snaps on/off or screws on/off, andthe like. In general, as used herein, the term “lid” denotes a means ofcontrolling user access to content compartment 1206.

FIG. 13B depicts a schematic drawing of a perspective view of yetanother alternative smart case that is configured for monitoring thecontents of a single, large-area reservoir content compartment inaccordance with the present disclosure. Case 1310 is analogous to case1300; however, case 1310 include a lid that is sub-divided into aplurality of lid sub-portions to discretize access to contentcompartment 1206. In addition, case 1310 includes sensor array 1314,which is configured to provide some measure of location information forcontent 1210.

In the depicted example, lid 318 is divided into lid sub-portions 1312Athrough 1312C. Typically, each lid sub-portion includes its own latchfor securing it to housing 1202.

In addition, electrode 1306-1 is sub-divided into a plurality ofsmaller-area electrodes (i.e., sub-electrodes 1306-1A, 1306-1B, and1306-1C) and electrode 1306-2 is sub-divided into a plurality ofsmaller-area electrodes (i.e., sub-electrodes 1306-2A, 1306-2B, and1306-2C).

As a result, sensor array 1314 comprises a plurality of smaller areacapacitors whose distribution provides locational information aboutcontent 1210 when it is contained in content compartment 1206. It shouldbe noted that the electrical shielding considerations described earlierin this disclosure are similarly applicable here.

In some embodiments, only one of electrodes 1312-1 and 1312-2 issubdivided into two or more smaller-area electrodes.

FIG. 14 depicts a schematic drawing of a cross-sectional view of analternative content compartment in accordance with the presentdisclosure. Content compartment 1400 is configured to accept content innon-tablet form such as, without limitation, liquids, suspensions,vapors, sprays, and the like.

Content compartment 1400 includes top and bottom walls 1402-1 and1402-2, strain sensor 1404, and nozzle 1406.

Each of top and bottom walls 1402-1 and 1402-2 comprises a resilientmaterial (e.g., silicone, rubber, plastic, composites, etc.) thatenables it to be deformed without damage. The flexibility of the top andbottom walls enables the contents of content compartment 1400 to beejected through nozzle 1406 by exerting pressure on the contentcompartment.

Top wall 1402-1 includes embedded strain sensor 1404, which provides anoutput signal when pressure is applied to content compartment 1400. Insome embodiments, bottom wall 1402-2 also includes a strain sensor.

Dispense nozzle 1406 is a conventional port that enables passage ofmaterial out of content compartment 1400 but blocks passage ofcontaminants from the outside environment into the content compartment.In some embodiments, nozzle 1406 is reconfigurable to enable refillingof content compartment 1400. In some embodiments, nozzle 1406 isconfigured as a spray head and content compartment 1400 is operativelycoupled with a pressurize source, such as compressed propellant.

In some embodiments, content compartment 1400 is configured to acceptprepackaged content. For example, in some embodiments, contentcompartment 1400 is configured to accept an over-the-counter vaporsource (e.g., nasal spray, etc.) contained in its own packaging. In someembodiments, content compartment 1400 is configured to accept andoperably coupled with a different medicinal cartridge (e.g., atraditional inhaler, etc.).

Depending upon the application and the product to be dispensed, in someembodiments, a content compartment is reusable or disposable. In someembodiments, the entire case is disposable.

For many patients, such as chronic-disease patients, it is necessary tosynchronize dosages of multiple medications, which represents a barrierto good adherence. For medications having similar dosing schedules, adose of each can be sorted into the same dispensing site. Formedications that are dosed differently, however, different doses can besorted into different sites. For each scenario, smart cases inaccordance with the present disclosure can be programmed to accommodatewhatever prescription regimen is required, thereby enabling a patient onmultiple medications to require only one case—a significant convenience.

It should be noted that, smart cases in accordance with the presentdisclosure designed for use with conventional blister cards (or other“push-through” formats) include dispense holes through which themedication is dispensed. In embodiments for use with loose pills thatare sorted into individual sites (either manually or by self-assembly),however, such dispense holes would enable the pills to fall through thecase bottom. In some embodiments, therefore, each of dispense holes 320includes a barrier, such as a flap, that functions as a Reed-type checkvalve. Such barriers can be incorporated in case body 316 or substrate502, or as a separate member.

FIGS. 15A-B depict schematic drawings of cross-sectional and top views,respectively, of portions of an alternative content compartment thatcomprises check valves in accordance with the present disclosure.Content compartment 1500 includes a plurality of sub-compartments 1502and a plurality of normally closed dispense holes 1504.

Each of sub-compartments 1502 is a chamber that is configured to holdtablets for one or more medications. Each of sub-compartments 1502 isdefined by partitions 1506 and bottom 1508.

Each of dispense holes 1504 is centered in the bottom 1512 of adifferent sub-compartment 1502 and includes a check valve 1510 thatprovides a barrier suitable for retaining the contents in its respectivesub-compartment until the user applies sufficient force to push thecontents through the check valve.

Check valve 1510 is an arrangement of triangularly shaped resilientflaps 1512, which are substantially co-planar in the absence of a forceapplied by the user on the content located in its respectivesub-compartment. In the depicted example, flaps 1512 comprise silicone;however, in some embodiments, flaps 1512 are made of a differentresilient material.

The mechanical properties of the valve (and the compliance of the flaps)matters of design and are typically based on the size and geometry ofdispense hole 1504, as well as the number and geometry, thickness, andmaterials of flaps 1512. Accordingly, the valve can be designed to allowa pill to be pushed through at a predetermined level of pressure/force,while securely preventing the pill from falling through the dispensehole under its own weight.

Content compartment 1500 provides reusable sites into which one or morepills can be placed to be dispensed by pushing them through whendesired. The contents of a site can be pushed through by applyingpressure/force directly onto it using, for example, a finger or stylus.

In some embodiments, content compartment 1500 is covered by a receiverwhose corresponding site holes comprise elastically deformable membranesthat isolate the pressure/force source from touching the content. Such areceiver can be configured to additionally aid in securing the contentsof sites in place and can be reusable or disposable depending on theapplication and need.

It is to be understood that the disclosure teaches just one example ofthe illustrative embodiment and that many variations of the inventioncan easily be devised by those skilled in the art after reading thisdisclosure and that the scope of the present invention is to bedetermined by the following claims.

1-25. (canceled)
 26. A smart case (100) for monitoring the state of acontent (1210) in a content compartment (1206), wherein the casecomprises: (1) an electronics module (102); and (2) a detection module(104) that includes: (i) a housing (302) having a lid (318) and a body(316), wherein the lid is movable relative to the body; (ii) the contentcompartment; and (iii) a sensor array (1208) that is operatively coupledwith the content; wherein the electronics module includes electroniccircuitry (112) that is configured to measure a first parameter across aportion of the content compartment.
 27. The case of claim 26 wherein thesensor array includes a plurality of electrodes (1216) that iselectrically coupled with the content, wherein the electronic circuitryis configured to generate a map of the parameter by making pair-wisemeasurements of an electrical parameter among the electrodes of theplurality thereof, and wherein the electrical parameter is selected fromthe group consisting of resistance, impedance, and capacitance.
 28. Thecase of claim 26 wherein the sensor array includes a plurality ofelectrodes (1216) that is electrically coupled with the content, andwherein the electronic circuitry is configured to generate a map of theparameter within the content compartment by performing a measurementtechnique via the plurality of electrodes, the measurement techniquebeing selected from the group consisting of electrical impedancetomography (EIT) and electrical capacitance tomography (ECT).
 29. Thecase of claim 27 wherein the lid includes a first electrode of theplurality of electrodes.
 30. The case of claim 27 wherein the contentcompartment includes a sidewall (1214) that includes a first electrodeof the plurality of electrodes.
 31. The case of claim 26 wherein thesensor array includes a plurality of electrodes that includes a firstelectrode (1306-1) and a second electrode (1306-2), and the contentcompartment includes a bottom (1212) that includes the first electrodeand the lid includes the second electrode.
 32. The case of claim 31wherein the lid includes a plurality of lid sub-portions (1312) and atleast one of the first electrode and second electrode includes aplurality of sub-electrodes (1306-1A through 1306-1C and/or 1306-2Athrough 1306-2C).
 33. The case of claim 26 wherein the contentcompartment includes: a wall (1402) that is deformable; a nozzle thatenables ejection of the content; and wherein the sensor array includes astrain sensor (1404) configured to provide an electrical signal inresponse to deformation of the wall, and wherein the first parameter isinduced strain in the wall.
 34. The case of claim 26 wherein the contentcompartment includes a plurality of sub-compartments (1502), eachsub-compartment including: a dispense hole (1504); and a check valve(1510) for inhibiting the passage of the content through its respectivedispense hole in the absence of pressure on the content.
 35. The case ofclaim 26 wherein the content compartment includes at least one recess(1222) that is configured to locate at least a portion of the content.36. The case of claim 26 further including a biosensor (348) that isconfigured to measure a user parameter selected from the groupconsisting of bio-impedance and bio-potential.
 37. The case of claim 26further comprising an environmental sensor (350) that provides an outputsignal based on at least one of an environmental factor and a usercondition, wherein the electronics module is further configured toprovide an alert to the user based on the output signal.
 38. The case ofclaim 26 wherein the content compartment is configured to accept thecontent as contained in a peel-away blister pack.
 39. The case of claim26 wherein the housing has an open state that enables access to thecontent compartment and a closed state that prevents access to thecontent compartment, and wherein the housing includes: a catch (326) anda clasp (322), wherein at least one of the catch and clasp iselectronically actuatable, and wherein the catch and clasp areconfigured to (1) engage and hold the housing in the closed state whenthe at least one of the catch and clasp is unactuated and (2) disengageand enable the open state when the at least one of the catch and claspis actuated; and at least one of a camera (346) and a fingerprint sensorconfigured to acquire a user feature, the user feature being selectedfrom the group consisting of a user image and a fingerprint; wherein theelectronic circuitry is configured to disengage the catch and clasp andenable relative motion between the lid and the body based on theacquired user feature.
 40. A method for monitoring the state of acontent (1210) in a content compartment (1206), wherein the methodcomprises: (1) providing a sensor array (1208) that is operativelycoupled with the content; (2) measuring a first parameter across aportion of the content compartment via the sensor array; and (3)estimating the state of the content based on the measured firstparameter.
 41. The method of claim 40 wherein the sensor array isprovided such that it includes a plurality of electrodes (1216) that isoperatively coupled with the content, and wherein the method furthercomprises: (4) performing pair-wise measurements of an electricalparameter between each pair of electrodes in the plurality thereof; and(5) generating a map of the first parameter over the portion of thecontent compartment, wherein the first parameter is based on theelectrical parameter.
 42. The method of claim 40 wherein the sensorarray is provided such that it includes a plurality of electrodes (1216)that is operatively coupled with the content, and wherein the methodfurther comprises (4) generating a map of the parameter within thecontent compartment by performing a measurement technique via theplurality of electrodes, the measurement technique being selected fromthe group consisting of electrical impedance tomography (EIT) andelectrical capacitance tomography (ECT).
 43. The method of claim 40wherein the sensor array is provided such that it includes a pluralityof electrodes (1216) that is operatively coupled with the content, andwherein the lid comprises at least one electrode of the pluralitythereof.
 44. The method of claim 40 further comprising (4) providing acase (1200) comprising a housing (1202) that includes the contentcompartment, wherein the content compartment includes a sidewall, andwherein the sensor array is provided such that it includes a pluralityof electrodes (1216) that is operatively coupled with the content, andwherein the sidewall comprises at least one electrode of the pluralitythereof.
 45. The method of claim 40 further comprising (4) providing acase (1300) comprising a housing (1202) that includes the contentcompartment, wherein the content compartment includes a bottom (1212),and wherein the sensor array is provided such that it includes aplurality of electrodes that includes a first electrode (1306-1) and asecond electrode (1306-2), and wherein the bottom includes the firstelectrode and the lid includes the second electrode.
 46. The method ofclaim 45 wherein the case is provided such that the lid includes aplurality of lid sub-portions (1312), and wherein the sensor array isprovided such that at least one of the first electrode and secondelectrode includes a plurality of sub-electrodes (1306-1A through1306-1C and/or 1306-2A through 1306-2C).
 47. The method of claim 40further comprising (4) providing a case (1200) comprising a housing(1202) that includes the content compartment, wherein the contentcompartment includes a wall (1402) that is deformable, and wherein thesensor array is provided such that it includes a strain sensor (1404)configured to provide the first parameter as a deformation of the wall.48. The method of claim 40 further comprising: (4) providing anenvironmental sensor (350) that provides an output signal based on atleast one of an environmental factor and a user condition; and (5)issuing an alert to the user based on the output signal.
 49. The methodof claim 40 further comprising: (4) providing a case (1200) comprising:(i) a housing (1202) that includes the content compartment, wherein thehousing is controllable between an open state that enables access to thecontent compartment and a closed state that prevents access to thecontent compartment; and (ii) a sensor that includes at least one of acamera (346) and a fingerprint sensor, the sensor being configured toacquire a user feature that is selected from the group consisting of auser image and a fingerprint; and (5) controlling the state of thehousing based on the acquired user feature.